Clement Nick D, Scott Chloe E H, Macpherson Gavin J, Simpson Philip M, Leitch Gillian, Patton James T, Ahmed Issaq, Amin Anish K, Gaston Paul, Goudie Ewan, Goudie Stuart, Macdonald Deborah M, Martinson Eliott, Moran Matthew, Wade Fazer
Edinburgh Orthopaedics, Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK.
Bone & Joint Research, London, UK.
Bone Jt Open. 2025 Feb 10;6(2):164-177. doi: 10.1302/2633-1462.62.BJO-2024-0155.R1.
Unicompartmental knee arthroplasty (UKA) is associated with an accelerated recovery, improved functional outcomes, and retention of anatomical knee kinematics when compared to manual total knee arthroplasty (mTKA). UKA is not universally employed by all surgeons as there is a higher revision risk when compared to mTKA. Robotic arm-assisted (ra) UKA enables the surgeon to position the prosthesis more accurately when compared to manual UKA, and is associated with improved functional outcomes and a lower early revision risk. Non-randomized data suggests that, when compared to mTKA, raUKA has a clinically meaningful greater functional benefit. This protocol describes a randomized controlled trial that aims to evaluate the clinical and cost-effectiveness of raUKA compared to mTKA for individuals with isolated medial compartment osteoarthritis (OA).
The total versus robotic-assisted unicompartmental knee arthroplasty (TRAKER) trial is a patient- and assessor-blinded, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary knee arthroplasty for primary medial compartment OA at a single NHS hospital (ClinicalTrials.gov NCT05290818). Participants will be randomly allocated on a 1:2 basis to either raUKA or mTKA, respectively. The primary analysis will compare the Oxford Knee Score (OKS) six months after surgery. Secondary outcomes measured at three, six, and 12 months include the OKS, Forgotten Joint Score, patient expectations, EuroQol five-dimension questionnaire (EQ-5D), and EQ-visual analogue scale (EQ-VAS), patient satisfaction, range of motion, postoperative complications, need for further surgery, resource use, and financial costs. Cost-effectiveness will be measured over a ten-year time span. A total of 159 patients will be randomized (n = 53 raUKA vs n = 106 mTKA) to obtain 80% power to detect a five-point difference in OKS between the groups six months after surgery.
The trial findings will provide evidence about the clinical and cost-effectiveness of raUKA compared to mTKA in patients with isolated medial compartment OA. This will inform future National Institute for Health and Care Excellence guidelines on primary knee arthroplasty in the UK.
与传统全膝关节置换术（mTKA）相比，单髁膝关节置换术（UKA）具有恢复快、功能预后改善以及保留膝关节解剖学运动学的特点。由于与mTKA相比UKA的翻修风险更高，并非所有外科医生都普遍采用该手术。与手动UKA相比，机器人手臂辅助（ra）UKA能使外科医生更精确地放置假体，且与更好的功能预后和更低的早期翻修风险相关。非随机数据表明，与mTKA相比，raUKA具有临床上更显著的功能优势。本方案描述了一项随机对照试验，旨在评估raUKA与mTKA相比，对孤立性内侧间室骨关节炎（OA）患者的临床疗效和成本效益。
全膝关节置换术与机器人辅助单髁膝关节置换术（TRAKER）试验是一项单盲、实用的平行双臂随机优效性试验，在一家英国国家医疗服务体系（NHS）医院对因原发性内侧间室OA接受择期初次膝关节置换术的成年人进行（ClinicalTrials.gov标识符：NCT05290818）。参与者将按1:2的比例随机分配至raUKA组或mTKA组。主要分析将比较术后6个月的牛津膝关节评分（OKS）。在术后3个月、6个月和12个月测量的次要结局包括OKS、遗忘关节评分、患者期望、欧洲五维健康量表（EQ-5D）和EQ视觉模拟量表（EQ-VAS）、患者满意度、活动范围、术后并发症、再次手术需求、资源使用和财务成本。成本效益将在10年时间跨度内进行评估。总共将随机分配159名患者（n = 53例raUKA组 vs n = 106例mTKA组），以获得80%的检验效能，检测术后6个月两组之间OKS有5分的差异。
该试验结果将为raUKA与mTKA相比在孤立性内侧间室OA患者中的临床疗效和成本效益提供证据。这将为英国国家卫生与临床优化研究所（National Institute for Health and Care Excellence）未来关于初次膝关节置换术的指南提供参考。
